Our injection moulded parts’ validation process evolved through our work with automotive OEMs. As a result, it reaches beyond the requirement of most other industries, but offers the reassurance of stringent quality protocols and a process that can be tailored to suit your component. We have found this method particularly useful for medical manufacturing.
During the Design for Manufacture stage of a project, a risk assessment of the product is performed and the outcome of this is formulated into an FMEA Process Flow flowchart, which will identify all potential failures in the design, manufacturing or assembly process. Our objective is to eliminate these risks before production commences.
When the FMEA is complete, we develop bespoke test and gauge methods that will mimic the component’s intended use and/or assembly interfaces. These tools are used by our quality engineers on the shop floor and our Metrology Department to check parts in the new project validation stage, and subsequently, each time they run in production.
The industry standard for business management systems.
The specific standard for medical devices. Highlighting traceability and cleanliness requirements.
The standard covers Quality Control Planning, Failure Mode and Effects Analysis (FMEA), Statistical Quality Control and Measurement System Analysis.
The industry standard with a series of requirements enabling an organisation to control its impact on the environment.
In addition to our ISO & IATF Accreditations, we are members of the AIAG (Automotive Industry Action Group). They are a not-for-profit consisting of automotive professionals who work collaboratively to streamline industry processes via global standards development & harmonised practices.
Our membership enables us to use the well regarded AIAG tools and resources to improve our own QMS, thus providing a better service to our clients.
If you’d like to find out more about our validation processes, please review the below: